An Observational Study to Assess Change in Disease Activity and Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in Real World

NCT ID: NCT05669794

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-21

Study Completion Date

2027-02-28

Brief Summary

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Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD.

Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Physician confirmed diagnosis of atopic dermatitis or atopic eczema at baseline.
* Symptom onset ≥1 year prior to baseline.
* Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
* The decision to prescribe upadacitinib is made prior to and independently of study participation.
* Participants who can understand and who are willing and able to complete the questionnaires, with parental support as required for adolescents.
* Participants (or legal representatives for adolescents) with a smartphone/tablet with internet access and willing to download the dedicated application to complete the questionnaires via this application.
* Participants (and legal representatives for adolescents) who have been informed verbally and in writing about this study before inclusion, and who do not object to their data being processed.
* Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.

Exclusion Criteria

* Participation in a clinical trial assessing an investigational drug, concurrently or within the last 30 days.
* Prior treatment with upadacitinib.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Ch Saint Quentin /Id# 249270

Saint-Quentin, Aisne, France

Site Status

CHU Clermont-Ferrand /ID# 248611

Clermont, Auvergne-Rhône-Alpes, France

Site Status

Hôpital Européen Marseille /ID# 257643

Marseille, Bouches-du-Rhone, France

Site Status

Hopital Saint Joseph /ID# 255537

Marseille, Bouches-du-Rhone, France

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Hopital Ponchaillou /ID# 251225

Rennes, Brittany Region, France

Site Status

CHU Dijon /ID# 248984

Dijon, Cote-d Or, France

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CH Georges Renon /ID# 248976

Niort, Deux-Sevres, France

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CHU de Besancon - Jean Minjoz /ID# 248642

Besançon, Doubs, France

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Hopitaux Drome Nord /ID# 248207

Romans-sur-Isère, Drome, France

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CH Valence /ID# 250693

Valence, Drome, France

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Centre Hospitalier de Quimper /ID# 251119

Quimper, Finistere, France

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CHU Montpellier - Hopital Saint Eloi /ID# 251877

Montpellier, Herault, France

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CHU nord - hopital Felix Guyon /ID# 250694

Saint-Denis, Le Reunion, France

Site Status

Centre Hospitalier Saint-Nazaire /ID# 251200

Saint-Nazaire, Loire-Atlantique, France

Site Status

Polyclinique Courlancy /ID# 250476

Reims, Marne, France

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Hopital du Scorff /ID# 251226

Lorient, Morbihan, France

Site Status

CHR Metz-Thionville - Hopital Bel-Air /ID# 252267

Thionville, Moselle, France

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Centre Hospitalier de Valenciennes /ID# 258642

Valenciennes, Nord, France

Site Status

Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 247209

Créteil, Paris, France

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Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 250807

Paris, Paris, France

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CHU de Nantes, Hotel Dieu -HME /ID# 262563

Nantes, Pays de la Loire Region, France

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Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251117

St-Priest-en-Jarez, Pays de la Loire Region, France

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HCL - Hopital Lyon Sud /ID# 248864

Pierre-Bénite, Rhone, France

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Centre Hospitalier du Mans /ID# 250510

Le Mans, Sarthe, France

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Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 252012

Chambéry, Savoie, France

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CH Pontoise - Hopital René Dubos /ID# 248843

Pontoise, Val-d Oise, France

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CH Avignon /ID# 251198

Avignon, Vaucluse, France

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CHI POISSY - Saint-Germain-en-Laye /ID# 248612

Saint-Germain-en-Laye, Yvelines, France

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Hopital Nord Amiens /ID# 250300

Amiens, , France

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Chu Angers /Id# 248674

Angers, , France

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CH Victor Dupouy /ID# 247216

Argenteuil, , France

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Centre Hospitalier de Béziers /ID# 264454

Béziers, , France

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Hopital Ambroise Pare /ID# 253337

Boulogne-Billancourt, , France

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CHU de CAEN - Hopital de la Cote de Nacre /ID# 252127

Caen, , France

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CH de Cahors /ID# 251190

Cahors, , France

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Centre Hospitalier de Calais /ID# 249449

Calais, , France

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Cabinet Dermatologie et Esthetique /ID# 247972

Cannes, , France

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CH William Morey /ID# 256417

Chalon-sur-Saône, , France

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CH Annecy Genevois - Site Annecy /ID# 249024

Epagny Metz Tessy, , France

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CH la Rochelle /ID# 252128

La Rochelle, , France

Site Status

CH Emile Roux Le Puy en Velay /ID# 248983

Le Puy-en-Velay, , France

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Hopital Saint Vincent de Paul /ID# 247218

Lille, , France

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CHU Limoges - Dupuytren 2 /ID# 251224

Limoges, , France

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Hopital Femme Mere Enfant /ID# 258682

Lyon, , France

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Cideazur /ID# 247905

Nice, , France

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Hôpital Saint-Louis /ID# 251228

Paris, , France

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Cabinet libéral du Dr KURIHARA /ID# 249664

Paris, , France

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Hopital Bichat-Claude Bernard /ID# 251274

Paris, , France

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CH de PAU /ID# 248567

Pau, , France

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Hôpital Charles-Nicolle /ID# 247215

Rouen, , France

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CHU de Rouen /ID# 250648

Rouen, , France

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Hôpital d'instruction des armées Bégin /ID# 247751

Saint-Mandé, , France

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Ch Salon de Provence /Id# 248829

Salon-de-Provence, , France

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Hôpital d'Instruction des Armées Sainte-Anne /ID# 247908

Toulon, , France

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CHU Toulouse - Hopital Larrey /ID# 247219

Toulouse, , France

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Hopital Nord Franche Comté /ID# 261628

Trévenans, , France

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Cabinet Liberal /ID# 251195

Villeurbanne, , France

Site Status

Hopital Prive d'Antony /ID# 247324

Antony, Île-de-France Region, France

Site Status

Hopital Pitie Salpetriere /ID# 253464

Paris, Île-de-France Region, France

Site Status

Countries

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France

Related Links

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Other Identifiers

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P23-628

Identifier Type: -

Identifier Source: org_study_id

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